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Also known as: 950769-58-1, Ac220, Quizartinib (ac220), Ac-220, Ac 220, Quizartinib hcl
Molecular Formula
C29H32N6O4S
Molecular Weight
560.7  g/mol
InChI Key
CVWXJKQAOSCOAB-UHFFFAOYSA-N
FDA UNII
7LA4O6Q0D3

Quizartinib
Quizartinib is an orally available small molecule with potential antineoplastic activity. Quizartinib selectively inhibits class III receptor tyrosine kinases, including FMS-related tyrosine kinase 3 (FLT3/STK1), colony-stimulating factor 1 receptor (CSF1R/FMS), stem cell factor receptor (SCFR/KIT), and platelet derived growth factor receptors (PDGFRs), resulting in inhibition of ligand-independent leukemic cell proliferation and apoptosis. Mutations in FLT3, resulting in constitutive activation, are the most frequent genetic alterations in acute myeloid leukemia (AML) and occur in approximately one-third of AML cases.
1 2D Structure

Quizartinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-(5-tert-butyl-1,2-oxazol-3-yl)-3-[4-[6-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea
2.1.2 InChI
InChI=1S/C29H32N6O4S/c1-29(2,3)25-17-26(33-39-25)32-27(36)30-20-6-4-19(5-7-20)22-18-35-23-9-8-21(16-24(23)40-28(35)31-22)38-15-12-34-10-13-37-14-11-34/h4-9,16-18H,10-15H2,1-3H3,(H2,30,32,33,36)
2.1.3 InChI Key
CVWXJKQAOSCOAB-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)C1=CC(=NO1)NC(=O)NC2=CC=C(C=C2)C3=CN4C5=C(C=C(C=C5)OCCN6CCOCC6)SC4=N3
2.2 Other Identifiers
2.2.1 UNII
7LA4O6Q0D3
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ac220 Compound

2.3.2 Depositor-Supplied Synonyms

1. 950769-58-1

2. Ac220

3. Quizartinib (ac220)

4. Ac-220

5. Ac 220

6. Quizartinib Hcl

7. Ac010220

8. Quizartinib Freebase

9. Ac 010220

10. Asp-2689

11. 1-(5-(tert-butyl)isoxazol-3-yl)-3-(4-(7-(2-morpholinoethoxy)benzo[d]imidazo[2,1-b]thiazol-2-yl)phenyl)urea

12. 7la4o6q0d3

13. Chembl576982

14. N-(5-tert-butylisoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

15. Chebi:90217

16. 950769-58-1 (free Base)

17. Ac-010220

18. 1132827-21-4 (hcl)

19. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-(4-{7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl}phenyl)urea

20. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-[4-[6-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea

21. N-(5-tert-butyl-isoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea Dihydrochloride

22. Chembl2386811

23. 1-(5-(tert-butyl)isoxazol-3-yl)-3-(4-(7-(2-morpholinoethoxy)-benzo[d]imidazo[2,1-b]thiazol-2-yl)phenyl)urea

24. N-(5-(1,1-dimethylethyl)isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1- B)benzothiazol-2-yl)phenyl)urea

25. N-(5-(1,1-dimethylethyl)isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)benzothiazol-2-yl)phenyl)urea

26. Urea, N-(5-(1,1-dimethylethyl)-3-isoxazolyl)-n'-(4-(7-(2-(4-morpholinyl)ethoxy) Imidazo(2,1-b)benzothiazol-2-yl)phenyl)-

27. Ac220 Compound

28. Ac220,quizartinib

29. Quizartinib [usan]

30. Quizartinib [usan:inn]

31. Quizartinibum

32. Unii-7la4o6q0d3

33. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)(1,3)benzothiazol-2-yl)phenyl)urea

34. N-(5-tert-butylisoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)(1,3)benzothiazol-2-yl)phenyl)urea

35. N-(5-tert-butylisoxazol-3-yl)-n'-[4-[7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea

36. Quizartinib, 95%

37. Quizartinib, Ac220

38. Quizartinib, Free Base

39. Ac220 - Quizartinib

40. Quizartinib [mi]

41. Quizartinib; Plx3397

42. Quizartinib [inn]

43. Quizartinib (usan/inn)

44. Quizartinib, Ac010220

45. Schembl72923

46. Quizartinib [who-dd]

47. Mls006011240

48. Gtpl5658

49. Dtxsid70241746

50. Bcpp000443

51. Hms3244k09

52. Hms3244k10

53. Hms3244l09

54. Hms3265g09

55. Hms3265g10

56. Hms3265h09

57. Hms3265h10

58. Hms3654j20

59. Hms3743g21

60. Bcp02224

61. Bdbm50300690

62. Mfcd18074524

63. Nsc756647

64. Nsc799659

65. Nsc800857

66. S1526

67. Zinc43204002

68. Akos015891557

69. Bcp9000223

70. Ccg-264906

71. Cs-0211

72. Db12874

73. Nsc-756647

74. Nsc-799659

75. Nsc-800857

76. Sb16610

77. Ncgc00242493-01

78. Ncgc00242493-02

79. Ncgc00242493-07

80. As-16178

81. Hy-13001

82. Smr004703000

83. Ft-0687630

84. Sw218131-2

85. D09955

86. J-524214

87. Q7272714

88. Brd-k93918653-001-01-4

89. 3-(5-tert-butyl-1,2-oxazol-3-yl)-1-(4-{10-[2-(morpholin-4-yl)ethoxy]-7-thia-2,5-diazatricyclo[6.4.0.0^{2,6}]dodeca-1(12),3,5,8,10-pentaen-4-yl}phenyl)urea

90. N-(5-tert-butyl-isoxazol-3-yl)-n''-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

91. N-(5-tert-butyl-isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-ylethoxy)imidazo(2,1-b) (1,3)benzothiazol-2-yl)phenyl)urea

92. N-(5-tert-butyl-isoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

93. N-[5-(1,1-dimethylethyl)-3-isoxazolyl]-n'-[4-[7-[2-(4-morpholinyl)ethoxy]imidazo[2,1-b]benzothiazol-2-yl]phenyl]urea

2.4 Create Date
2008-09-08
3 Chemical and Physical Properties
Molecular Weight 560.7 g/mol
Molecular Formula C29H32N6O4S
XLogP35.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count8
Exact Mass560.22057470 g/mol
Monoisotopic Mass560.22057470 g/mol
Topological Polar Surface Area134 Ų
Heavy Atom Count40
Formal Charge0
Complexity849
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of acute myeloid leukaemia.


Treatment of acute myeloid leukaemia


5 Pharmacology and Biochemistry
5.1 Pharmacology

In preclinical studies, Quizartinib demonstrated dose-dependent activity and favorable drug-like profiles in bioavailability, pharmacokinetics, cytochrome P450 (CYP) liability, and absorption, distribution, metabolism, excretion (ADME).


5.2 ATC Code

L01XE


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EX - Other protein kinase inhibitors

L01EX11 - Quizartinib


5.3 Mechanism of Action

Quizartinib potently inhibits FLT3, a kinase that is mutated in approximately one-third of acute myeloid leukemia cases, and patients with FLT3 mutations are less responsive to traditional therapies.


API SUPPLIERS

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Lee Fine Chem

India

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Macleods Pharmaceuticals Limited

India

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Daishang Pharmchem Group

China

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Drugs in Development

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Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.


Lead Product(s): Quizartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 13, 2025

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01

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 13, 2025

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Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Quizartinib,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 13, 2025

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02

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 13, 2025

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Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Failure.


Lead Product(s): Quizartinib,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 18, 2024

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COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Failure.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 18, 2024

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Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Quizartinib,Rufinamide

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 18, 2024

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04

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 18, 2024

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Details:

VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.


Lead Product(s): Quizartinib,Cytarabine,Daunorubicin

Therapeutic Area: Oncology Brand Name: Vanflyta

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 10, 2024

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COMPAMED
Not Confirmed
COMPAMED
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Details : VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

Product Name : Vanflyta

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 10, 2024

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Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Leukemia.


Lead Product(s): Quizartinib,Daunorubicin,Idarubicin Hydrochloride,Cytarabine

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 29, 2024

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COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Leukemia.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 29, 2024

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  • Development Update

Details:

Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.


Lead Product(s): Quizartinib,Etoposide,Dexrazoxane,Mitoxantrone,Cytarabine,Methotrexate,Daunorubicin,Fludarabine Phosphate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Daiichi Sankyo

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 16, 2024

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Princess Maxima Center for Pediatric Oncology

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Princess Maxima Center for Pediatric Oncology

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COMPAMED
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Details : Quizartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 16, 2024

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Details:

VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.


Lead Product(s): Quizartinib,Cytarabine,Daunorubicin

Therapeutic Area: Oncology Brand Name: Vanflyta

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 09, 2023

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COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

Product Name : Vanflyta

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 09, 2023

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Details:

Vanflyta (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.


Lead Product(s): Quizartinib,Cytarabine,Daunorubicin

Therapeutic Area: Oncology Brand Name: Vanflyta

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 15, 2023

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09

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Vanflyta (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

Product Name : Vanflyta

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 15, 2023

blank

Details:

VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.


Lead Product(s): Quizartinib,Cytarabine,Daunorubicin

Therapeutic Area: Oncology Brand Name: Vanflyta

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 09, 2023

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10

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

Product Name : Vanflyta

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 09, 2023

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Kizartinibdihydroklorid

Brand Name : Vanflyta

Dosage Form : Film Coated Tablet

Dosage Strength : 17.7mg

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Approval Date : 06/11/2023

Application Number : 20220627000076

Regulatory Info : Approved

Registration Country : Sweden

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Kizartinibdihydroklorid

Brand Name : Vanflyta

Dosage Form : Film Coated Tablet

Dosage Strength : 26.5mg

Packaging :

Approval Date : 06/11/2023

Application Number : 20220627000083

Regulatory Info : Approved

Registration Country : Sweden

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Quizzical

Brand Name : VANFLYTA

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 31/03/2025

Application Number : 69710

Regulatory Info : Allowed

Registration Country : Switzerland

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Quizzical

Brand Name : VANFLYTA

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

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Approval Date : 31/03/2025

Application Number : 69710

Regulatory Info : Allowed

Registration Country : Switzerland

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FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds
It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  

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#PharmaFlow by PHARMACOMPASS
28 Aug 2025

NEWS #PharmaBuzz

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Patents & EXCLUSIVITIES

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US Patents

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8836218

Drug Substance Claim :

Drug Product Claim :

Application Number : 216993

Patent Use Code : U-3661

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-23

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8883783

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216993

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-03-16

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8357690

Drug Substance Claim :

Drug Product Claim :

Application Number : 216993

Patent Use Code : U-3661

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-02-26

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8883783

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216993

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-03-16

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 7968543

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216993

Patent Use Code : U-3661

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-08-15

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 9555040

Drug Substance Claim :

Drug Product Claim :

Application Number : 216993

Patent Use Code : U-3661

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-05-14

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8557810

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216993

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-03-16

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8865710

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216993

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-08-15

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 8836218

Drug Substance Claim :

Drug Product Claim :

Application Number : 216993

Patent Use Code : U-3661

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-23

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QUIZARTINIB DIHYDROCHLORIDE

US Patent Number : 9675549

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216993

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-30

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Looking for 950769-58-1 / Quizartinib API manufacturers, exporters & distributors?

Quizartinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Quizartinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Quizartinib manufacturer or Quizartinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quizartinib manufacturer or Quizartinib supplier.

PharmaCompass also assists you with knowing the Quizartinib API Price utilized in the formulation of products. Quizartinib API Price is not always fixed or binding as the Quizartinib Price is obtained through a variety of data sources. The Quizartinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Quizartinib

Synonyms

950769-58-1, Ac220, Quizartinib (ac220), Ac-220, Ac 220, Quizartinib hcl

Cas Number

950769-58-1

Unique Ingredient Identifier (UNII)

7LA4O6Q0D3

About Quizartinib

Quizartinib is an orally available small molecule with potential antineoplastic activity. Quizartinib selectively inhibits class III receptor tyrosine kinases, including FMS-related tyrosine kinase 3 (FLT3/STK1), colony-stimulating factor 1 receptor (CSF1R/FMS), stem cell factor receptor (SCFR/KIT), and platelet derived growth factor receptors (PDGFRs), resulting in inhibition of ligand-independent leukemic cell proliferation and apoptosis. Mutations in FLT3, resulting in constitutive activation, are the most frequent genetic alterations in acute myeloid leukemia (AML) and occur in approximately one-third of AML cases.

Quizartinib Manufacturers

A Quizartinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quizartinib, including repackagers and relabelers. The FDA regulates Quizartinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quizartinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Quizartinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Quizartinib Suppliers

A Quizartinib supplier is an individual or a company that provides Quizartinib active pharmaceutical ingredient (API) or Quizartinib finished formulations upon request. The Quizartinib suppliers may include Quizartinib API manufacturers, exporters, distributors and traders.

click here to find a list of Quizartinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Quizartinib GMP

Quizartinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Quizartinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Quizartinib GMP manufacturer or Quizartinib GMP API supplier for your needs.

Quizartinib CoA

A Quizartinib CoA (Certificate of Analysis) is a formal document that attests to Quizartinib's compliance with Quizartinib specifications and serves as a tool for batch-level quality control.

Quizartinib CoA mostly includes findings from lab analyses of a specific batch. For each Quizartinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Quizartinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Quizartinib EP), Quizartinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quizartinib USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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